Kornimate/medical-research-clean huggingface dataset:
the use of isocapnic hyperventilation (ihv) for treatment of methanol poisoned patients

Conditions: Methanol Poisoning

Summary: the projects investigate if treatment with isocapnic hyperventilation can eliminate methanol from the body in a similar manner to dialysis. this is achieved by administering the antidote (fomepizole) and let the patient breathe on a isocapnic hyperventilation device while samples of blood, urine and maybe the breath are collected to measure the contents of methanol and its metabolites.

isocapnic hyperventilation (ihv) the normal physiology breathing is a careful balance between the number of breaths per minute (rate/min) and the depth of each breath (tidal volume, vt). together they make up the minute ventilation (mv), where mv= rate x vt). to maintain stable homeostasis in the organism, the minute ventilation is closely regulated to maintain adequate uptake of oxygen and adequate elimination of the carbon dioxide (co2) that is produced by the metabolism. too low minute ventilation leads to a buildup of co2 and decrease in blood ph (respiratory acidosis), while hyperventilation (too high minute ventilation) leads to an excess loss of co2 and increase in blood ph (respiratory alkalosis). the same mechanism will also enable the organism to compensate any metabolic disturbances (up to a certain point): a metabolic acidosis will be counteracted by a hyperventilation, whereas a metabolic alkalosis will be counteracted by a hypoventilation, both with the ultimate goal of keeping the acidity (as given by the ph) as closely regulated as possible. the concept of isocapnic hyperventilation (ihv) allows the person to hyperventilate while keeping the co2 within normal limits at the same time. the clearmate (thornhill research inc., canada) adds co2 to the inspired air to compensate to the increased loss induced by the increased minute ventilation. this means that hyperventilation can occur, and a wash-out of volatile substances such as methanol will happen without disrupting the important co2 balance.

Eligibility criteria:
inclusion criteria: * adult patients, men \& women diagnosed with methanol poisoning * serum-methanol ≥ 50 mg/dl (16 mm) * ph ≥ 7.0, and correctable by bicarbonate infusion * no (newly developed) visual disturbances exclusion criteria: * acidosis requiring haemodialysis (ph \<7.0), or acidosis that is not responding in spite of aggressive buffer (bicarbonate) treatment within maximum 1-2 hours. * comatose patients * newly developed visual disturbances * adh not fully blocked with antidotes, and not responding to additional dosing of fomepizole. will be identified by a continuous or increasing anion gap (ag) or base excess (be) on the blood gas machine.

Keywords: isocapnic hyperventilation
bioavailability of a new formulation of nasal naloxone for prehospital use

Conditions: Drug Overdose

Summary: overdose with potential deadly outcome is a serious problem among opioid abusers, not least in norway. the annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. those who inject heroin or other opioids are considered to have the highest risk for death from overdose. to save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. usually naloxone is injected into a muscle or a blood vessel. administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. this is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. a pilot study in this hospital has shown no significant side effects or adverse reaction. while significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. therefore this preclinical study in healthy volunteers will be undertaken.


Eligibility criteria:
inclusion criteria: * healthy * normal electrocardiogram (ecg) * hemoglobin: male 13.4 - 17.0 g/dl, female 11,7- 15.3 g/dl * creatinine: male 60- 105 micromol/l female 45- 90 micromol/l * asat: male 15- 45 u/l, female 15- 35 u/l * alat: male 10- 70 u/l female 10- 45 u/l * gamma gt: male 10- 80 u/l female 10- 45 u/l * hcg normal under 3 ye/l * fertile women must use safe contraception and have a negative serum hcg at inclusion exclusion criteria: * taking any medications including herbal medicines the last week prior to first treatment visit * history of drug abuse * history of prior drug allergy * having any local nasal disease or nasal surgery or recent cold for the last week * pregnancy * fertile women not using high efficacy contraceptives (oral contraceptives, patch (evra), implants, vaginal ring, hormonal iud, copper iud, sterilization) throughout the study period until their last visit. * lactating women * any reason why, in the opinion of the investigator, the patient should not participate

Keywords: emergency treatment morphine derivates heroin antidotes administration, intranasal
arteriopathy and endothelial function

Conditions: Peripheral Arterial Disease

Summary: to determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value


Eligibility criteria:
inclusion criteria: * peripheral arteriopathy * stable cardio-respiratory status exclusion criteria: * dialysis

Keywords: arteriopathy endothelial function fruit juice
inp105 proof-of-concept study for the acute treatment of agitation in adolescents and young adults with asd

Conditions: Agitation in Adolescents and Young Adults With ASD

Summary: this is a phase 2a, proof-of concept, 2-way, 2-period crossover, double-blind study to evaluate the safety and efficacy of inp105 as an acute treatment versus placebo in adolescents and young adults with autism spectrum disorder (asd) experiencing agitation. approximately 32 asd patients who are currently being treated for agitation/aggression at several inpatient units specializing in behavioral treatment will be enrolled. inp105 is a novel combination product that sprays a powder formulation of olanzapine to the upper nasal space. an earlier formulation showed a similar extent, but faster rate of absorption compared to the approved intramuscular product. in this study, 5 mg of olanzapine or placebo will be delivered nasally by this combination product to moderately or severely agitated participants. participants will undergo several screening assessments, including observation session(s) of episode(s) of agitation resulting from a frustration task (eg, a non-preferred activity). at least one observation session must result in a documented moderate to severe agitation episode prior to the participant being eligible to enroll in the study and be randomized to treatment. the study will be conducted in 2 phases. a pilot phase will initially enroll at least 6 participants, who will receive both 5 mg inp105 (5 mg olanzapine) and placebo in random order, in the same crossover design as later participants. participants will be dosed during a documented moderate to severe episode of agitation. once 6 participants have completed both dosing periods and have at least 48 hours of post-dose safety data collected, a safety and preliminary efficacy analysis will be performed by an independent unblinded statistical group, and a summary report forwarded to a sponsor-led data and safety review committee (dsrc), who will remain blinded. enrollment will be paused during the dsrc pilot phase safety and preliminary efficacy results review. absent any concerning safety signals, the second phase will enroll all remaining participants. the dsrc may suggest revisions to the protocol, and the protocol amended and approved as necessary, prior to further participants being enrolled.


Eligibility criteria:
inclusion criteria: * confirmed autism spectrum disorder diagnosis * admitted as an inpatient to a behavioral unit prior to informed consent * displays episodes of moderate to severe agitation exclusion criteria: * hypersensitivity to olanzapine * history of severe head trauma, stroke, endocrine disorder, or cardiovascular disease * history of hypotension * currently on a chronic dose of olanzapine * currently taking ciprofloxacin, enoxacin, fluvoxamine, or carbamazepine

Keywords: agitation olanzapine autism
prognostic value of mrd detection in ca125 non-sensitive ovarian cancer patients

Conditions: Ovarian Cancer

Summary: ovarian cancer ranks third in the incidence of gynecologic malignancies, while mortality ranks first. the tumor marker ca125 is the most concerned tumor marker in the clinical monitoring prognosis of ovarian cancer, and an elevated ca125 indicates a later stage and a worse prognosis. however about 20% of patients with ovarian cancer have low ca125 expression. therefore, ca125 is not sensitive to some ovarian cancers with a high risk of recurrence. how to improve the diagnostic performance of these ca125-insensitive patients is a difficult problem in current research. minimal residual disease (mrd) refers to the residual tumor components in the body of tumor patients after achieving complete remission through treatment. mrd detection is mainly achieved by liquid biopsy, and residual tumor components can be detected by circulating tumor dna (ctdna). this study aims to explore the value of mrd (ctdna) in the risk assessment of ca125 non sensitive ovarian cancer populations by combining ctdna with traditional imaging and serological tumor markers.


Eligibility criteria:
inclusion criteria: * age 18-75; * pathologically confirmed ovarian cancer; * ca125 ≤200u/ml at first diagnosis or recurrence; * physical condition score ps ≤ 2 points; * enough tumor samples for wes detection; * patients and their families can understand and are willing to participate in this study and provide written informed consent. exclusion criteria: * patients unable to provide sufficient tissue / blood samples for research detection; * pregnant or lactating women; * other diseases considered by the research doctor to affect the prognosis and survival;
trial comparing one-stage with two-stage basilic vein transposition

Conditions: Brachiobasilic Arteriovenous Fistula

Summary: arteriovenous fistulas (avfs) are made by joining a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and clear the blood from wastes, in patients whose kidneys are destroyed and cannot provide this function. the success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. one of the veins used for an avf is the basilic vein, located at the upper arm. this vein is however deeply located and necessitates movement (transposition) during surgery to a less deep and lateral path before it is joined to the artery, in order to be used. a single study has shown that surgery performed in two parts (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure altogether. the aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein avf), with the difference that the vein will be relocated outside the main wound, a method that is widely accepted as being better.

arteriovenous fistulas (avfs) are made by anastomosing a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and perform hemodialysis in patients with renal failure. the success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. one of the veins used for an avf is the basilic vein, located at the upper arm. this vein is however deeply located and necessitates transposition during surgery to a less deep and lateral subcutaneous plane before the anastomosis with the artery, in order to be used. a single study has shown that surgery performed in two stages (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure in one stage. the aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein avf), with the difference that the basilic vein will be relocated outside the main wound, a method that is widely accepted as being better.

Eligibility criteria:
inclusion criteria: * chronic renal failure on hemodialysis * chronic renal failure with anticipated hemodialysis exclusion criteria: * patient unwillingness, not consenting * cephalic vein options * basilic vein less than 2.5 mm * basilic vein with intrinsic lesions, unsuitable for use

Keywords: chronic renal failure basilic vein transposition fistula
sleep quality, stress, depression, blood pressure responses to diaphragmatic respiratory exercise in systemic sclerosis

Conditions: Systemic Sclerosis

Summary: systemic sclerosis women usually report problems such as stress/depression, fatigue, not deep sleep. complementary therapies may improve the reported problems in those patients

the assignment of females with systemic sclerosis (n= forty females) to two equal groups. the group will contain 20 females. the first group will receive tele-supervised diaphragmatic respiratory exercise ( applied at the homes of the females two times per the day, at the morning and at the evening, twenty minutes for every time, the sessions will be applied daily for 3 months in all females). the females in the second group will be waiting-list control females.

Eligibility criteria:
inclusion criteria: * systemic sclerosis women (40 females) exclusion criteria: * obesity * thoracic diseases * heart disease * females with mental diseases
evaluation of barriers to postpartum care in hiv infected women

Conditions: HIV Infection; Pregnancy

Summary: the purpose of this study is to evaluate why the majority of hiv infected women in the harris county health district system who are pregnant do not come to clinic for their hiv disease after they have a baby through questionaires administered prepartum and questionaires and structured interviews postpartum. the study will ask subjects questions about hiv, drug use, depression and social problems.

this study is evaluating information pre and postpartum to assess what are barriers to patients coming into care for hiv after they have a baby. we will try to evaluate recurrent themes in questionaires and interviews to try and identify the barriers to care.

Eligibility criteria:
inclusion criteria: hiv infected pregnant women who * hiv-infected women who are pregnant by confirmatory tests or an hiv positive woman who has had a baby within the last 6 months and is coming to care postpartum. * women who intend to get care at harris county hospital district. * subjects must be \>18 years old. exclusion criteria: * women unable to complete questionnaires. * women who are unable to speak, read, or understand english or spanish.
policy to practice: statewide rollout of ymca childhood obesity standards

Conditions: Childhood Obesity

Summary: the investigators long term-goal is to help ymca programs across the nation successfully acheive the y of usa "healthy eating and physical activity standards". our objective here is threefold. first, the investigators will work with south carolina ymca leadership to achieve the "healthy eating and physical activity standards" and implement our hepa strategies in ymca programs across the state, evaluate the uptake of and adherence to the standards and strategies, and identify factors that influence their implementation. second, the investigators will evaluate the impact of acheiving the standards on children's mvpa and the serving and consumption of fv and water during the programs. third, the investigators will evaluate the costs associated with and the cost-effectiveness of meeting the standards in terms of improvements in activity and healthy eating.

the investigators research team developed a conceptual framework that identifies critical modifiable levers within out of school time programs that can be altered and/or strengthened to reach policy or standards goals. these include the policy environment at the national, state and local levels; characteristics of the individual site, program leadership, staff, and children; and existing outside organizational partnerships. this framework was informed by complex systems change, social ecology, systemic capacity building , and the literature on the impact of public health policy that identifies key elements of the system to be targeted as well as possible influences on those elements. viewing ost programs as complex systems, "healthy eating and physical activity standards" represent one of many leverage points within a system. existing efforts to implement standards rest solely upon the voluntary adoption of the standards, with little to no other changes to the ost program setting. it is clear from our preliminary work and comprehensive reviews that ost programs are falling short of meeting goals set forth in the standards.

Eligibility criteria:
inclusion criteria: * all children enrolled in participating afterschool programs will be eligible to take part in the study. exclusion criteria: * any physical/orthopedic impairment that would limit a child's ability to participate in regular physical activity (e.g., wheelchair user).
study of chiglitazar compare with placebo in type 2 diabetes patients

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the efficacy and safety of chiglitazar, compare with placebo.

the efficacy and safety will be compared between chiglitazar and placebo after treatment of 24 weeks. the long term efficacy and safety of chiglitazar will be evaluated after 52 weeks treatment.

Eligibility criteria:
inclusion criteria: 1. meet the who diagnostic criteria for type 2 diabetes (published on 1999); 2. hba1c≥ 7.5% and ≤ 10.0% after control of diet and exercises; 3. male and female,age between 18 and 70 years; 4. bmi between 18.5-35kg/m2; 5. willing to be assigned to any treatment arm and sign inform consent. exclusion criteria: 1. type 1 diabetes; 2. treated by oral or injective antidiabetic drug before screening, including insulin and herb; 3. fasting plasma glucose \> 13.3 mmol/l (240 mg/dl); 4. resistant hypertension \[blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least 4 different classes of drugs\]; 5. plasma triglyceride \> 500 mg/dl (5.65 mmol/l); 6. is treating by fibrates; 7. history of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy; 8. had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months; 9. history of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery; 10. heart failure (nyha classification stage iii or iv), or left ventricular hypertrophy indicated by ecg; 11. hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase \> 2.5 fold of the upper limit of the normal range; 12. kidney diseases or serum creatinine exceed the normal range: male \> 133 μmol/l or female \>108 μmol/l; 13. had malignancy in the past 5 years, not including basal cell carcinoma; 14. had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers; 15. have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors; 16. edema with unknown reason; 17. alcohol or drug addiction; 18. had participated other drugs' clinical trials in the 3 months before screening; 19. pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception; 20. any condition that make investigator consider the subject is not suitable to participate the trial.

Keywords: chiglitazar,diabetes,type 2 diabetes
measurement skin temperature during pulsed laser exposure

Conditions: Port-Wine Stain

Summary: lasers are the treatment modality of choice for port wine stain birthmarks.the epidermis is not totally spared due to partial absorption of energy therein by melanin that presents an optical barrier through which the light must pass to reach the underlying blood vessels. absorption of laser energy by melanin causes localized heating in the epidermis, which may, if not controlled, produce permanent complications such as hypertrophic scarring or dyspigmentation.

the researchers want to establish a correlation between non-invasive skin temperature measurements and the minimum laser energy during skin laser treatment using cryogen spray cooling. this study would eliminate the need for test pulses to estimate the safe and acceptable radiant exposure prior to laser treatment.

Eligibility criteria:
inclusion criteria: * 7 years of age and older with diagnosis of port wine stain birthmark * 18 years of age and older with no port wine stain * non-pregnant women * apparent good health exclusion criteria: * age less than 7 years old * pregnant women * history of photodermatoses or skin cancer * current use of photosensitizing drugs
evaluation of patient satisfaction in hepatitis c patients treated with pegintron pen and rebetol in romania (study p04301)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: the objective of this study is to evaluate patient satisfaction in hepatitis c patients receiving pegintron pen plus rebetol. the rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. since the pegintron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in pegintron pen use.


Eligibility criteria:
inclusion criteria: * patients with hepatitis c under treatment with pegintron pen and rebetol in romania. exclusion criteria: * not applicable